New P. Falciparum Malaria Drug as Effective as Standard

Pyronaridine-artesunate once daily works as well as twice-daily artemether-lumefantrine

By Lindsey Marcellin

HealthDay Reporter

FRIDAY, April 23 (HealthDay News) -- Pyronaridine-artesunate, a new anti-malarial drug that can be given once a day, is as effective as the current standard Plasmodium falciparum malaria treatment, artemether-lumefantrine, which requires twice-daily dosing, according to a study in the April 24 issue of The Lancet.

Antoinette K. Tshefu, M.D., of the Université de Kinshasa in the Democratic Republic of the Congo, and colleagues conducted a double-blind, phase III trial in which they randomized patients to receive either pyronaridine-artesunate once a day or artemether-lumefantrine twice a day for three days, plus respective placebo. The final analysis included 784 patients on pyronaridine-artesunate and 386 patients on artemether-lumefantrine; patients ranged in age from 3 to 60 years.

The researchers found that the polymerase chain reaction-corrected adequate clinical and parasitological response rate at 28 days was 99.5 percent for the study drug and 99.2 percent for the standard drug. The rate of adverse events in each group was 60 and 57 percent, respectively, and most of the adverse events were due to the disease itself. Hepatic enzyme elevations were noted in the pyronaridine-artesunate group but not the artemether-lumefantrine group. The researchers' analysis (which took into account patients who did not complete the follow-up) found a lower rate of reinfection and a longer time to reinfection (day 28 versus day 21) in the pyronaridine-artesunate group than in the artemether-lumefantrine group.

"The efficacy of pyronaridine-artesunate still has to be assessed in a real-life setting across the wider population of patients who need anti-malarial treatment, including those who are malnourished or have anemia. However, in view of the results of this study and with a purchase price for pyronaridine-artesunate in the range of less than U.S.$1 for adults and less than $0.50 for children, this drug combination should be considered for inclusion in malaria treatment programs," the authors write.

The study was funded by Shin Poong Pharmaceutical, which employs one study author.